Suzan Onel

Suzan Onel

K&L Gates LLP

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Latest Posts › FDA


President Obama Signs Federal GMO Law, Preempts Vermont Law

On July 29, 2016, U.S. President Barack Obama signed into law the first U.S. federal law requiring food manufacturers and distributors to label products that contain genetically modified organisms (“GMO”).[1] The law...more

8/8/2016 - Bioengineering Disclosure Requirements FD&C Act FDA Food Labeling Food Manufacturers GMO Preemption USDA

The Future of Medical Device Manufacturing Is Here: FDA Issues Draft Guidance on Technical Considerations for 3D Printing

A few years ago, a custom-fabricated bioresorbable tracheal splint saved the life of an infant suffering from a collapsed bronchus due to severe tracheobronchomalacia. The splint was implanted around the baby’s airway,...more

8/1/2016 - 3D Printing Additive Manufacturing FDA Manufacturers Medical Devices

How Americans Eat: Unveiling of the New Nutrition Facts Label

Over a decade in the making, the U.S. Food and Drug Administration (“FDA” or the “Agency”) recently issued two final rules revising its nutrition labeling regulations, most notably, the Nutrition Facts label. The revisions...more

6/23/2016 - FDA Final Rules Food Labeling Food Manufacturers Nutrition Facts Labels Recordkeeping Requirements

U.S. FDA Finalizes Medical Foods Guidance

On May 12, 2016, the U.S. Food and Drug Administration (“FDA” or “Agency”) finalized its 2013 draft guidance for industry, “Frequently Asked Questions About Medical Foods; Second Edition.” Despite significant industry...more

6/2/2016 - FDA FDCA Final Guidance Food Labeling Medical Foods

Vermont Act 120 and Beyond: Genetically Engineered Foods, Where Are We Now?

On July 1, 2016, Vermont’s genetically engineered food labeling law is set to become effective. Act 120 and its implementing rule (Vermont Consumer Protection Rule 121) require food manufacturers to label food products that...more

5/13/2016 - Exemptions FDA FDCA Food Labeling Food Manufacturers GMO New Legislation Preemption Proposed Legislation

FDA's Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices

Between January 20 and February 9, 2015, the U.S. Food and Drug Administration (“FDA”) issued four guidances related to its policies toward low risk devices. These guidances were largely developed as an outgrowth from FDA’s...more

3/12/2015 - FDA FDASIA Healthcare Medical Device Accessories Medical Devices Mobile Apps New Guidance Popular

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

4/9/2014 - Australia China Dietary Supplements EU FDA FDCA Food Labeling Food Safety Generic Drugs Medical Devices Nutritional Supplements Prescription Drugs

Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more

12/17/2012 - FDA FDCA First Amendment Marketing Misbranding Off-Label Promotion Off-Label Use Pharmaceutical Industry

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